ISPAN PERFLUOROPROPANE C3F8 GAS
FDA premarket approval P900066/S009 · decided 2010-01-13
Approval details
- PMA number
- P900066
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ISPAN PERFLUOROPROPANE C3F8 GAS
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 2009-08-13
- Decision date
- 2010-01-13
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE CLARIFICATION OF THE GAS PRESSURE RESTRICTION LISTED ON THE GAS CYLINDER LABEL AND ENHANCED INSTRUCTION FOR FILLING A SYRINGE WITH ISPAN PERFLUOROPROPANE C3F8 GAS.
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